US5512297A - Sustained release heterodisperse hydrogel systems for insoluble drugs - Google Patents
Sustained release heterodisperse hydrogel systems for insoluble drugs Download PDFInfo
- Publication number
- US5512297A US5512297A US08/447,235 US44723595A US5512297A US 5512297 A US5512297 A US 5512297A US 44723595 A US44723595 A US 44723595A US 5512297 A US5512297 A US 5512297A
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- US
- United States
- Prior art keywords
- sustained release
- medicament
- release excipient
- percent
- agent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J3/00—Processes of treating or compounding macromolecular substances
- C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
- C08J3/03—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
- C08J3/075—Macromolecular gels
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dispersion Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Abstract
Description
TABLE 1 ______________________________________ PREPARATION OF SUSTAINED-RELEASE EXCIPIENT Component % - Ex. 1 % - Ex. 2 % - Ex. 3 ______________________________________ 1. Xanthan Gum 25 25 25 2. Locust Bean Gum 25 25 25 3. Calcium Sulfate 0 5 20 4. Dextrose 50 45 30 5. Water 150 ml 123 ml 123 ml ______________________________________
TABLE 2 ______________________________________ TABLET FORMULATION - EXAMPLES 1-3 Component % ______________________________________ 1. Sustained-Release Excipient 83.1 2. Nifedipine 8.31 3. PEG 3350 8.31 4. Pruv ®* 0.25 ______________________________________ *Sodium Stearyl Fumarate
TABLE 3 ______________________________________ Time (hr) Ex. 1 Ex. 2 Ex. 3 ______________________________________ 4 14.7 27.4 15.6 8 42.2 47.9 43.0 12 59.2 60.3 58.8 16 80.7 68.2 65.6 20 91.8 84.2 74.5 24 97.2 89.6 79.7 ______________________________________
TABLE 4 ______________________________________ Component % ______________________________________ 1. Xanthan Gum 25 2. Locust Bean Gum 25 3. Calcium Sulfate 10 4. Dextrose 35 5. Ethyl Cellulose 5 6. Ethyl Alcohol 10* ______________________________________ *removed during processing
TABLE 5 ______________________________________ Component % ______________________________________ 1. Sustained Release Excipient 78.9 2. Nifedipine 7.9 3. PEG 3350 7.9 4. Surelease ® 5.3 5. Water 16.8* ______________________________________ *removed during processing
TABLE 6 ______________________________________ Time (hr) Ex. 4 Ex. 5 Ex. 6 ______________________________________ 4 34.1 33.6 37.0 8 69.1 66.0 71.7 12 87.0 86.3 88.9 16 94.3 93.6 95.7 20 97.5 97.1 98.6 24 98.8 98.7 100.1 ______________________________________
TABLE 7 ______________________________________ Component % ______________________________________ 1. Xanthan Gum 25 2. Locust Bean Gum 25 3. Calcium Sulfate 10 4. Dextrose 35 5. Ethyl Cellulose 5 6. Ethyl Alcohol 10* ______________________________________ *removed during processing
TABLE 8 ______________________________________ Component % - Ex. 7 % - Ex. 8 % - Ex. 9 ______________________________________ 1. TIMERx ® 78.4 81.3 83.5 2. Nifedipine 7.8 6.8 6.0 3. PEG 3350 7.8 6.8 6.0 4. Ethylcellulose 5.2 4.5 4.0 5. Pruv ® 0.8 0.7 0.6 ______________________________________
TABLE 9 ______________________________________ Time (hr) Ex. 7 Ex. 8 Ex. 9 ______________________________________ 4 11.3 9.0 9.3 8 26.9 22.1 20.4 12 48.8 36.5 30.8 16 69.5 51.2 45.0 20 76.3 65.2 60.4 24 80.8 79.9 73.0 ______________________________________
TABLE 10 ______________________________________ Percent Included Component Ex. 10 Ex. 11 Ex. 12 Ex. 13 Ex. 14 ______________________________________ Xanthan Gum 0 5 12.5 25 37.5 Locust Bean 0 5 12.5 25 37.5 Gum Calcium Sulfate 10 10 10 10 10 Dextrose 85 75 60 35 10 Ethyl Cellulose 5 5 5 5 5 Ethyl Alcohol 10* 10* 10* 10* 10* ______________________________________ *removed during processing
TABLE 11 ______________________________________ Component % ______________________________________ 1. Sustained-Release Excipient 78.4 2. Nifedipine 7.8 3. PEG 3350 7.8 4. Ethylcellulose 5.2 5. Pruv ® 0.8 ______________________________________
TABLE 12 ______________________________________ Dissolution Time (hr) Ex. 10 Ex. 11 Ex. 12 Ex. 13 Ex. 14 ______________________________________ 4 91.7 49.3 34.1 21.8 24.0 8 91.7 85.8 69.1 59.4 49.9 12 91.7 91.1 87.0 84.8 83.8 16 91.7 93.1 94.3 101.3 91.2 20 91.7 93.1 97.5 105.3 92.9 24 91.7 93.1 98.8 106.5 92.9 ______________________________________
TABLE 13 ______________________________________ Dissolution Rate Time (hr) Ex. 10 Ex. 11 Ex. 12 Ex. 13 Ex. 14 ______________________________________ 4 91.7 49.3 34.1 21.8 24.0 8 0.0 36.5 35.0 37.6 25.9 12 0.0 5.3 17.9 25.4 33.9 16 0.0 2.0 7.3 16.5 7.4 20 0.0 0.0 3.2 4.0 1.7 24 0.0 0.0 1.3 1.2 0.0 ______________________________________
TABLE 14 ______________________________________ Component % ______________________________________ 1. Xanthan Gum 25 2. Locust Bean Gum 25 3. Compactrol 10 4. Emdex 35 5. Ethyl Cellulose 5 6. Ethyl Alcohol 5* ______________________________________ *removed during processing
TABLE 15 ______________________________________ Component % ______________________________________ 1. Sustained-Release Excipient 78.44 2. Nifedipine 7.84 3. PEG 3350 7.84 4. Pruv ® 0.24 5. Surelease ® 5.64 6. Ethyl Alcohol (75 ml)* ______________________________________ *removed during processing
250C(Ru/Rs).sub.2
TABLE 16 ______________________________________ Percent Dissolved Time (hr) Ex. 15A Ex. 15 ______________________________________ 4 12.76 13.53 8 36.89 42.99 12 73.06 63.27 16 98.07 73.69 20 102.07 78.95 24 106.33 87.88 ______________________________________
Claims (16)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/447,235 US5512297A (en) | 1993-09-09 | 1995-05-22 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/118,924 US5455046A (en) | 1993-09-09 | 1993-09-09 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US08/447,235 US5512297A (en) | 1993-09-09 | 1995-05-22 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/118,924 Division US5455046A (en) | 1993-09-09 | 1993-09-09 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
Publications (1)
Publication Number | Publication Date |
---|---|
US5512297A true US5512297A (en) | 1996-04-30 |
Family
ID=22381584
Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/118,924 Expired - Lifetime US5455046A (en) | 1993-09-09 | 1993-09-09 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US08/447,236 Expired - Lifetime US5554387A (en) | 1993-09-09 | 1995-05-22 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US08/447,235 Expired - Lifetime US5512297A (en) | 1993-09-09 | 1995-05-22 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US08/651,901 Expired - Lifetime US5667801A (en) | 1993-09-09 | 1996-05-21 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US08/843,573 Expired - Lifetime US5846563A (en) | 1993-09-09 | 1997-04-18 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US09/207,298 Expired - Lifetime US6136343A (en) | 1993-09-09 | 1998-12-08 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/118,924 Expired - Lifetime US5455046A (en) | 1993-09-09 | 1993-09-09 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US08/447,236 Expired - Lifetime US5554387A (en) | 1993-09-09 | 1995-05-22 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
Family Applications After (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/651,901 Expired - Lifetime US5667801A (en) | 1993-09-09 | 1996-05-21 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US08/843,573 Expired - Lifetime US5846563A (en) | 1993-09-09 | 1997-04-18 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US09/207,298 Expired - Lifetime US6136343A (en) | 1993-09-09 | 1998-12-08 | Sustained release heterodisperse hydrogel systems for insoluble drugs |
Country Status (11)
Country | Link |
---|---|
US (6) | US5455046A (en) |
EP (2) | EP1101489B1 (en) |
JP (1) | JP4077886B2 (en) |
AT (2) | ATE318586T1 (en) |
CA (1) | CA2131647C (en) |
DE (3) | DE69434640T2 (en) |
DK (1) | DK0642785T3 (en) |
ES (2) | ES2254274T3 (en) |
GR (1) | GR950300035T1 (en) |
IL (1) | IL110744A (en) |
PT (2) | PT1101489E (en) |
Cited By (52)
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US6039980A (en) * | 1996-01-29 | 2000-03-21 | Edward Mendell Co., Inc. | Sustained release excipient |
US6048548A (en) * | 1993-09-09 | 2000-04-11 | Edward Mendell Co., Inc. | Sustained release heterodisperse hydrogel systems-amorphous drugs |
US6056977A (en) * | 1997-10-15 | 2000-05-02 | Edward Mendell Co., Inc. | Once-a-day controlled release sulfonylurea formulation |
US6093420A (en) * | 1996-07-08 | 2000-07-25 | Edward Mendell Co., Inc. | Sustained release matrix for high-dose insoluble drugs |
US6136343A (en) * | 1993-09-09 | 2000-10-24 | Edward Mendell Co., Inc. | Sustained release heterodisperse hydrogel systems for insoluble drugs |
US6261601B1 (en) | 1997-09-19 | 2001-07-17 | Ranbaxy Laboratories Limited | Orally administered controlled drug delivery system providing temporal and spatial control |
US6416786B1 (en) | 1998-12-11 | 2002-07-09 | Nostrum Pharmaceuticals, Inc. | Sustained release tablet containing hydrocolloid and cellulose ether |
US6540993B1 (en) | 1995-06-27 | 2003-04-01 | Wyeth | Method of treating inflammatory bowel disease using a topical formulation of IL-11 |
US6555139B2 (en) | 1999-06-28 | 2003-04-29 | Wockhardt Europe Limited | Preparation of micron-size pharmaceutical particles by microfluidization |
US20030091635A1 (en) * | 2001-09-26 | 2003-05-15 | Baichwal Anand R. | Opioid formulations having reduced potential for abuse |
US20030129234A1 (en) * | 2001-07-06 | 2003-07-10 | Penwest Pharmaceuticals Company | Methods of making sustained release formulations of oxymorphone |
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DE642785T1 (en) | 1995-09-28 |
US5667801A (en) | 1997-09-16 |
IL110744A (en) | 1998-12-27 |
JP4077886B2 (en) | 2008-04-23 |
US6136343A (en) | 2000-10-24 |
ATE318586T1 (en) | 2006-03-15 |
ES2254274T3 (en) | 2006-06-16 |
EP0642785A3 (en) | 1996-11-06 |
US5554387A (en) | 1996-09-10 |
PT642785E (en) | 2002-02-28 |
CA2131647C (en) | 1999-08-10 |
ES2070810T3 (en) | 2001-12-16 |
JPH07165615A (en) | 1995-06-27 |
US5455046A (en) | 1995-10-03 |
ATE207742T1 (en) | 2001-11-15 |
IL110744A0 (en) | 1994-08-22 |
EP0642785A2 (en) | 1995-03-15 |
ES2070810T1 (en) | 1995-06-16 |
EP1101489B1 (en) | 2006-03-01 |
DK0642785T3 (en) | 2001-12-31 |
US5846563A (en) | 1998-12-08 |
PT1101489E (en) | 2006-05-31 |
EP0642785B1 (en) | 2001-10-31 |
DE69434640D1 (en) | 2006-04-27 |
DE69434640T2 (en) | 2006-08-10 |
GR950300035T1 (en) | 1995-07-31 |
CA2131647A1 (en) | 1995-03-10 |
EP1101489A3 (en) | 2001-09-19 |
DE69428853T2 (en) | 2002-04-11 |
EP1101489A2 (en) | 2001-05-23 |
DE69428853D1 (en) | 2001-12-06 |
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